Details for New Drug Application (NDA): 208079
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NDA 208079 describes SERNIVO, which is a drug marketed by Primus Pharms and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SERNIVO profile page.
The generic ingredient in SERNIVO is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.
The generic ingredient in SERNIVO is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.
Summary for 208079
| Tradename: | SERNIVO |
| Applicant: | Primus Pharms |
| Ingredient: | betamethasone dipropionate |
| Patents: | 7 |
Pharmacology for NDA: 208079
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 208079
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SERNIVO | betamethasone dipropionate | SPRAY;TOPICAL | 208079 | NDA | Primus Pharmaceuticals, Inc. | 68040-714 | 68040-714-08 | 1 BOTTLE, SPRAY in 1 CARTON (68040-714-08) / 10 g in 1 BOTTLE, SPRAY |
| SERNIVO | betamethasone dipropionate | SPRAY;TOPICAL | 208079 | NDA | Primus Pharmaceuticals, Inc. | 68040-714 | 68040-714-28 | 1 BOTTLE, SPRAY in 1 CARTON (68040-714-28) / 120 g in 1 BOTTLE, SPRAY |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;TOPICAL | Strength | EQ 0.05% BASE/SPRAY | ||||
| Approval Date: | Feb 5, 2016 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PLAQUE PSORIASIS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PLAQUE PSORIASIS | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Aug 31, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF PLAQUE PSORIASIS | ||||||||
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